Non-Surgical Treatment of Periodontitis in Menopausal Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of polyunsaturated fatty acids (PUFAs) [omega-3] as an adjunctive treatment to scaling and root planing for menopausal women with periodontitis versus scaling and root alone as a non- surgical treatment .
. The main question it aims to answer is:
• to investigate the effect of systemic administration of Omega-3 fatty acids in addition to SRP on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women.
Participants will given * a soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months along with non-surgical treatment (group2)
** a soft gelatin capsules containing olive oil to be consumed directly once daily for 12 months along with non-surgical treatment (group1)
Researchers will compare group 1 to group 2 to see if PUFAs has an effect on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women. .
详细描述
Menopause is typically accompanied by significant systemic and oral manifestations, including hormonal changes and increased susceptibility to periodontal disease, which may involve inflammatory biomarkers like aspartate aminotransferase (AST) and Osteocalcin in gingival crevicular fluid (GCF). The study aims to evaluate the effectiveness of regular inoculation of polyunsaturated fatty acids (PUFAs) as an adjunctive treatment for menopausal women's periodontitis.
Methods: Twenty elderly women with chronic periodontitis were split evenly into two groups by random assignment. Patients in group II (the research group) were given soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months, as opposed to the group I (the control group), who received soft gelatin capsules containing some olive oil (placebo). Scaling and root planning (SRP) were used to address periodontal disease in all cases.
At baseline, six and twelve months after treatment, clinical indicators and AST and Osteocalcin amounts in the GCF will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
an independent researcher not directly involved in the study, utilized a computer generated random number sequence to assign participants to either the control or study group. this randomization was executed before the commencement of the treatment phase.
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as; periodontitis patients
- •presence of a minimum of 6 teeth in the mouth
- •at least 3 periodontal sites with probing pocket depth more or equal to 5mm
- •women experiencing menopause for at least a year
排除标准
- •women suffering from any systemic disorder that might affect the periodontal tissues such as; Diabetes Mellitus, immune disorders,..
- •anemic patients
- •patients taking NSAIDs, supplements, antibiotics regularly used mouthwashes within the last 3 months
- •participants in any other clinical trials
研究组 & 干预措施
group 2 polyunsaturated fatty acids
intervention: systemic administration of 1000 mg polyunsaturated fatty acids. to be taken once daily with meals for 12 months
patients treated by scaling and root planing and oral systemic administration of Omega-3 fatty acids a soft gelatinous capsule containing 1000 mg polyunsaturated fatty acids (PUFAs)
干预措施: Polyunsaturated Fatty Acids (Drug)
group 1 control
control group, patients treated by scaling and root planing and an oral soft gelatinous capsule containing olive oil to be taken once daily with meals for 12 months
干预措施: olive oil (Dietary Supplement)
结局指标
主要结局
aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).
时间窗: baseline, 6 months, 12 months
AST in GCF will be measured in 20 participants, evaluation of AST in the collected GCF. The assessment was done using the VITROS Dry Technology 60 Chemistry System which can provide accurate results using even very small amounts of GCF (\~10 µl). The principle behind the test is to evaluate the enzymatic activity of AST to convert the amino group of aspartates where the oxidation process of nicotinamide adenine dinucleotide (NAD) + hydrogen (H) (NADH+). This activity is measured by the Reflectance Spectrophotometry at 340nm wavelength and 37°C. The change in rate assesses the enzymatic activity as per Bergmeyer et al. method.
Osteocalcin in gingival crevicular fluid (GCF).
时间窗: baseline, 6 months, 12 months
Osteocalcin in GCF, The evaluation of the level of osteocalcin in the GCF sample, using enzyme-linked immunosorbent assay (ELISA) kits (Ani Biotech Oy, AvioBion, Finland), is the next step in the study. The osteocalcin levels are measured in nanograms per milliliter (ng/mL) when assessed using ELISA kits. The principle applied in the sandwich-type ELISA kit is the presence of a monoclonal osteocalcin which is adsorbed onto the well of the kit and then binds to the osteocalcin (present in the sample). The amount of osteocalcin present was assessed using standard curves based on dilutions and measured at the color intensity of 450nm.
次要结局
- Plaque Index (PI)(baseline, 6 months, 12 months)
- Gingival index (GI)(baseline, 6 months, 12 months)
- Probing pocket depth (PPD)(baseline, 6 months, 12 months)
- Clinical attachment level (CAL)(baseline, 6 months, 12 months)
研究者
Hadir F. El-Dessouky
Professor Dr
King Abdulaziz University